← Product Code [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA) · K042037 # M2A MAGNUM SYSTEM (K042037) _Biomet, Inc. · KWA · Oct 1, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K042037 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA.md) - **Decision Date:** Oct 1, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3330 - **Device Class:** Class 3 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The M2a™ Magnum™ System is indicated for use in patients requiring total hip replacement due to the following: Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis. Rheumatoid arthritis . Correction of functional deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision of previously failed total hip arthroplasty ## Device Story M2a™ Magnum™ System is a metal-on-metal hip prosthesis consisting of a CoCrMo monolithic acetabular cup and a CoCrMo modular femoral head. Smaller heads (38-40mm) feature a one-piece design; larger heads (42-60mm) utilize a titanium adapter for modularity. Designed for use with Biomet Type I taper femoral components. Implanted by orthopedic surgeons in a hospital setting during total hip arthroplasty or revision surgery. Device replaces damaged hip joint surfaces to restore function and reduce pain associated with degenerative joint disease or trauma. ## Clinical Evidence No clinical data was used to establish substantial equivalence. Evidence is based on bench-top mechanical testing. ## Technological Characteristics Materials: CoCrMo (monolithic acetabular cup, modular femoral head), titanium (adapter). Design: Metal-on-metal semi-constrained hip prosthesis. Components: Uncemented acetabular cup, modular femoral heads (38-60mm). Compatibility: Biomet Type I taper femoral components. Mechanical testing performed to verify performance. ## Regulatory Identification A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). ## Predicate Devices - M2a™ Acetabular System 38mm ([K011110](/device/K011110.md)) - Bio-Moore Endo Heads ([K984028](/device/K984028.md)) - New Bio-Moore Endo Head, Taper Adapter ([K002106](/device/K002106.md)) - Conserve® Plus Spiked Shell and Conserve® Total 56mm Femoral Head ([K031963](/device/K031963.md)) - Metal Transcend® Articulation System ([K021249](/device/K021249.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ OCT 1 - 2004 K04 2037 Image /page/0/Picture/2 description: The image shows the logo for BIOMET INC. The logo is in black and white and features a stylized "B" followed by the letters "IOMET" in a bold, sans-serif font. The letters are all capitalized, and the "INC" is smaller and placed to the right of the "T". ### 510(k) Summary of Safety and Effectiveness Biomet Manufacturing Corp. T Applicant/Sponsor: Kacy Arnold Contact Person: Regulatory Specialist M2a™ Magnum™ System Proprietary Name: Metallic Acetabular Articulation Common Name: Classification Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis (888.3330) #### Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The M2a™ Magnum™ System is substantially equivalent to: - K011110 M2a™ Acetabular System 38mm (Biomet) ■ - K984028 Bio-Moore Endo Heads (Biomet) 프 - K002106 New Bio-Moore Endo Head, Taper Adapter (Biomet) 내 - K031963 Conserve® Plus Spiked Shell and Conserve® Total 56mm Femoral Head (Wright ﺎ Medical) - 피 K021249 Metal Transcend® Articulation System (Wright Medical) ### Device Description: The M a ™ Maqnum™ System consists of a CoCrMo monolithic acetabular cup, which articulates with a CoCrMo modular head. The smaller femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from –6mm to +12mm. The larger femoral heads, sizes 42mm to 60mm, are a modular design with neck length variations ranging from -6mm to +9mm, achieved through the use of a titanium adapter assembled with the modular head component at the time of surgery. The femoral heads may be used in conjunction with any of Biomet's commercially available Type I taper femoral component. - Summary of Technologies: The Magnum™ Hip System technological characteristics (material and design) are similar to predicate devices. - Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices. Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices. All trademarks are property of Biomet, Inc. {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service OCT 1 - 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Kacy Arnold, RN, MBA Biomet Manufacturing Corp. P.O. Box 587 Warsaw, IN 46581-0587 Re: K042037 Trade Name: M2a™ Magnum™ System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis Regulatory Class: III Product Code: KWA Dated: July 28, 2004 Received: July 29, 2004 Dear Ms. Arnold: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Kacy Arnold This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark M. Wilkerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use K042037 510(k) Number (if known): Device Name: M²a™ Magnum™ Hip System ## Indications For Use: The M³a™ Magnum™ System is indicated for use in patients requiring total hip replacement due to the following: - Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis. - Rheumatoid arthritis . - · Correction of functional deformity - · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques - · Revision of previously failed total hip arthroplasty Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Division Sign-Off) **Division of General, Restorative, and Neurological Devices** 2 Number K042037 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K042037](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K042037) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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